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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIODYNAMICS NANOKNIFE SYSTEM LOW ENERGY DIRECT CURRENT ABLATION DEVICE

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ANGIODYNAMICS NANOKNIFE SYSTEM LOW ENERGY DIRECT CURRENT ABLATION DEVICE Back to Search Results
Model Number 20300101
Device Problems Device Stops Intermittently (1599); Insufficient Information (3190)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 03/17/2016
Event Type  malfunction  
Manufacturer Narrative
It was reported that the nanoknife system (sn (b)(4)) involved in the incident is available to be returned to the manufacturer for evaluation. To date, the generator has yet to be returned. Attempts are being made to obtain the unit. An investigation into the root cause for the event is currently in process. A review of the device history records was performed for the serial number (b)(4). The review confirms that the unit met all material, assembly, and performance specifications. The results of the unit evaluation will be sent via a follow up medwatch. (b)(4).
 
Event Description
As reported (b)(6) 2016, a (b)(6) male patient presented for an ire (irreversible electroporation) procedure of the pancreas. During the procedure, the nanoknife system unexpectedly shut down approximately 5 times. The first time was after 2 high currents during a 6 probe ire. The additional 4 shut downs occurred without a high current approximately 5 - 15 minutes in sequence. Each time, the unit was restarted and the procedure was resumed. As there was a delay in the procedure due to the unit malfunction, it is assumed the patient was under anesthesia for an extended time. It was reported that the patient suffered no adverse effects due to the event. It was reported the nanoknife system is available for return to the manufacturer for evaluation.
 
Manufacturer Narrative
The nanoknife generator (sn (b)(4)) was returned for evaluation and repair. The unit was received in good condition. During assessment the generator was tested at multiple settings per hardware unit testing procedures and the unit did not shut down as reported. The unit functioned as intended and the reported failure could not be replicated. The unit was tested per manufacturing operational verification procedure and met all acceptance criteria. The customer's reported complaint description of the unit shutting down and delay in procedure is confirmed based on information provided by the treating physician, however the failure could not be replicated during testing of the generator. The root cause for the failure could not be determined as no defects were found with the generator during testing. The user manual (nanoknife user manual, 160-105261 rev 01 version 2. 2. 1), instructs the user to reboot the system to let the auto-test check the system. Repeat any portions of ablation that were not delivered. A review of the lot history records for the disposable nanoknife probe associated with the event was performed for the packaging lot (151008) for catalog number 20400101 obtained through a ship history report for any deviations related to the reported defect of the complaint. The review confirms that the packaging lots and all component lots met all material, assembly, and performance specifications. A review of the angiodynamics complaint system noted no trends for this complaint type and product family. This type of complaint will continue to be monitored for trends. (b)(4).
 
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Brand NameNANOKNIFE SYSTEM
Type of DeviceLOW ENERGY DIRECT CURRENT ABLATION DEVICE
Manufacturer (Section D)
ANGIODYNAMICS
603 queensbury avenue
queensbury NY 12804
Manufacturer (Section G)
ANGIODYNAMICS
603 queensbury avenue
queensbury NY 12804
Manufacturer Contact
law ryan
603 queensbury avenue
queensbury, NY 12804
5187424488
MDR Report Key5573396
MDR Text Key42524159
Report Number1319211-2016-00055
Device Sequence Number1
Product Code OAB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102329
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/18/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/13/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number20300101
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/06/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/18/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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